PACKAGE LEAFLET: INFORMATION FOR THE USER. FULVESTRANT TEVA 250 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE Fulvestrant

Transcription

1 PACKAGE LEAFLET: INFORMATION FOR THE USER FULVESTRANT TEVA 250 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE Fulvestrant Read all of this leaflet carefully before you start using this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See Section 4. What is in this leaflet 1. What is and what it is used for 2. What you need to know before you use 3. How to use 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. What is and what it is used for contains the active substance fulvestrant, which belongs to the group of estrogen blockers. Estrogens, a type of female sex hormones, can in some cases be involved in the growth of breast cancer. is used either: alone, to treat postmenopausal women with a type of breast cancer called estrogen receptor positive breast cancer that is locally advanced or has spread to other parts of the body (metastatic), or in combination with palbociclib to treat women with a type of breast cancer called hormone receptorpositive, human epidermal growth factor receptor 2-negative breast cancer, that is locally advanced or has spread to other parts of the body (metastatic). Women who have not reached menopause will also be treated with a medicine called a luteinizing hormone releasing hormone (LHRH) agonist. When fulvestrant is given in combination with palbociclib, it is important that you also read the package leaflet for palbociclib. If you have any questions about palbociclib, please ask your doctor. 2. What you need to know before you use Do NOT use if you: - are allergic to fulvestrant or any of the other ingredients of this medicine (listed in section 6) - are pregnant or breast-feeding (see section Pregnancy, breast-feeding and fertility ) - have severe liver problems. Warnings and precautions Talk to your doctor, pharmacist, or nurse before using if any of these apply to you: - kidney or liver problems - low numbers of platelets (which help blood clotting) or bleeding disorders - previous problems with blood clots - osteoporosis (loss of bone density) - alcoholism (see section contains ethanol 96% (alcohol) ). 1

2 The efficacy and safety of fulvestrant (either as monotherapy or in combination with palbociclib) have not been studied in patients with critical visceral disease. Children and adolescents is NOT indicated in children and adolescents under 18 years. Other medicines and Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. In particular, you should tell your doctor if you are using anticoagulants (medicines to prevent blood clots). Pregnancy, breast-feeding and fertility You MUST NOT use if you are pregnant. If you can become pregnant, you should use effective contraception while being treated with. You MUST NOT breast-feed while on treatment with. Driving and using machines is not expected to affect your ability to drive or use machines. However, if you feel tired after treatment, DO NOT drive or use machines. contains ethanol 96% (alcohol), i.e. up to 1000 mg per dose, equivalent to 20 ml beer or 8 ml wine per dose. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy. contains benzyl alcohol, the amount of benzyl alcohol per dose is 500 mg per 5 ml (100 mg per 1 ml), which may cause allergic reactions. 3. How to use Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is 500 mg fulvestrant (two 250 mg/5 ml injections) given once a month with an additional 500 mg dose given 2 weeks after the initial dose. Your doctor or nurse will give you as a slow intramuscular injection, one into each of your buttocks. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. You may need immediate medical treatment if you experience any of the following side effects: allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and/or throat that may be signs of anaphylactic reactions thromboembolism (increased risk of blood clots)* inflammation of the liver (hepatitis) liver failure. 2

3 Tell your doctor, pharmacist, or nurse if you notice any of the following side effects: Side effects reported in patients treated with monotherapy: Very common: may affect more than 1 in 10 people injection site reactions, such as pain and/or inflammation abnormal levels of liver enzymes (in blood tests)* nausea (feeling sick) weakness, tiredness* joint and musculoskeletal pain hot flushes skin rash allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and/or throat. All other side effects: Common: may affect up to 1 in 10 people headache vomiting (being sick), diarrhoea, or loss of appetite* urinary tract infections back pain* increase of bilirubin (bile pigment produced by the liver) thromboembolism (increased risk of blood clots)* decreased levels of platelets (thrombocytopenia) vaginal bleeding lower back pain irradiating to leg on one side (sciatica) sudden weakness, numbness, tingling, or loss of movement in your leg, especially on only one side of your body, sudden problems with walking or balance (peripheral neuropathy). Uncommon: may affect up to 1 in 100 people thick, whitish vaginal discharge and candidiasis (infection) bruising and bleeding at the site of injection increase of gamma-gt, a liver enzyme seen in a blood test inflammation of the liver (hepatitis) liver failure numbness, tingling and pain anaphylactic reactions. * Includes side effects for which the exact role of cannot be assessed due to the underlying disease. Side effects reported in patients treated with in combination therapy with palbociclib: Very common: may affect more than 1 in 10 people neutrophil count decrease (neutropenia) white blood cell count decrease (leukopenia) infections tiredness nausea (feeling sick) reduction in red blood cells (anaemia) inflammation or ulceration of the mouth 3

4 diarrhoea decreased levels of platelets (thrombocytopenia) vomiting (being sick) hair loss rash loss of appetite fever. Common: may affect up to 1 in 10 people feeling weak increased level of liver enzymes loss of taste nosebleed excessively wet eye dry skin blurred vision dry eye. Uncommon: may affect up to 1 in 100 people fever with other signs of infection (febrile neutropenia). Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via: Ireland HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: ; Fax: Website: medsafety@hpra.ie Malta ADR Reporting Website: By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton or syringe labels after EXP. The expiry date refers to the last day of that month. Do not use this medicine if you notice any particles or discolouration prior to administration. Store and transport refrigerated (2 C - 8 C). Temperature excursions outside 2 C - 8 C should be limited. This includes avoiding storage at temperatures exceeding 25 C, and not exceeding a 28 day period where the average storage temperature for the product is below 25 C (but above 2 C - 8 C). After temperature excursions, the product should be returned immediately to the recommended storage conditions (store and transport refrigerated 2 C - 8 C). Temperature excursions have a cumulative effect on the product quality and the 28 day time period must not be exceeded over the duration of the 2-year shelf life of. Exposure to temperatures below 2 C will not damage the product providing it is not stored below 20 C. 4

5 Keep the pre-filled syringe in the original package, in order to protect from light. Your health care professional will be responsible for the correct storage, use and disposal of Fulvestrant Teva. This medicine may pose a risk to the aquatic environment. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What contains - The active substance is fulvestrant. Each pre-filled syringe contains 250 mg fulvestrant. Each ml of solution contains 50 mg of fulvestrant. - The other ingredients (excipients) are ethanol (96%), benzyl alcohol, benzyl benzoate and castor oil, refined. What looks like and contents of the pack is a clear, colourless to yellow, viscous solution in a pre-filled syringe fitted with a Luer- Lock connector, containing 5 ml solution for injection. Two syringes must be administered to receive the 500 mg recommended monthly dose. has 2 pack presentations: - 1 pack containing 1 glass pre-filled syringe and 1 safety needle for connection to the barrel. - 1 pack containing 2 glass pre-filled syringes and 2 safety needles for connection to each barrel are also provided. Not all pack sizes may be marketed. Marketing Authorisation Holder Teva B.V. Swensweg GA Haarlem The Netherlands Manufacturer Pliva Croatia Ltd. Prilaz baruna Filipovica Zagreb Croatia Teva Pharmaceutical Works Private Limited Company Táncsics Mihály út 82 H-2100 Gödöllő Hungary This medicinal product is authorised in the Member States of the EEA under the following names: Austria: Belgium: Bulgaria: Croatia: Fulvestrant ratiopharm 250 mg Injektionslösung in einer Fertigspritze 250 mg oplossing voor injectie/solution injectable/injektionslösung Фулвестрант Тева 250 mg нжекционен разтвор в πредварително наπълнена сπринцовка Fulvestrant Pliva 250 mg otopina za injekciju u napunjenoj štrcaljki 5

6 Czech Republic: Denmark: Estonia: Finland: France: Germany: Hungary: Iceland: Ireland: Italy: Latvia: Lithuania: Luxembourg: Malta: Netherlands: Poland: Portugal: Romania: Slovakia: Slovenia: Spain: Sweden: United Kingdom: 250 mg injektioneste, liuos, esitäytetty ruisku 250 mg solution injectable en seringue préremplie 250 mg Injektionslösung in einer Fertigspritze 250 mg/5 ml oldatos injekció előretöltött fecskendőben 250 mg stungulyf, lausn í áfylltri sprautu 250 mg Solution for Injection in Pre-filled Syringe 250 mg šķīdums injekcijām pilnšļircē 250mg injekcinis tirpalas užpildytame švirkšte 250 mg oplossing voor injectie/solution injectable/injektionslösung 250mg Solution for Injection in Pre-Filled Syringe 250 mg, oplossing voor injectie voorgevulde spuit 250 mg soluţie injectabilă în seringă preumplută 250 mg 250 mg raztopina za injicirnaje v napolnjeni injekcijski brizgi 250mg solutión inyectable en jeringa precargada EFG 250 mg injektionsvätska, lösning, förfylld spruta 250mg solution for injection in pre-filled syringe This leaflet was last revised in April The following information is intended for healthcare professionals only: 500 mg (2 x 250 mg/5 ml solution for injection) should be administered using two prefilled syringes (see section 3). Instructions for administration Administer the injection according to the local guidelines for performing large volume intramuscular injections. NOTE: Due to the proximity of the underlying sciatic nerve, caution should be taken if administering at the dorsogluteal injections site (see section 4.4). Warning - DO NOT autoclave safety needle before use. Hands MUST remain behind the needle at all times during use and disposal. For each of the two syringes: 6

7 Remove glass syringe barrel from tray and check that it is not damaged. Peel open the safety needle outer packaging. Parental solutions must be inspected visually for particulate matter and discolouration prior to administration. Hold the syringe upright on the ribbed part (C). With the other hand, take hold of the cap (A) and carefully twist the cap counter-clockwise until the cap disconnects for removal (see Figure 1). Remove the cap (A) off in a straight upward direction. To maintain sterility DO NOT TOUCH THE STERILE SYRINGE TIP (Luer-Lock) (B) (see Figure 2). Figure 1 Figure 2 Attach the safety needle to the Luer-Lock and twist until firmly seated (see Figure 3). Check that the needle is locked to the Luer connector before moving out of the vertical plane. Transport filled syringe to point of administration. Pull shield straight off needle to avoid damaging needle point. Figure 3 Expel excess gas from the syringe. Administer intramuscularly slowly (1-2 minutes/injection) into the buttock (gluteal area). For user convenience, the needle bevel-up position is oriented to the lever arm (see Figure 4). Figure 4 After injection, immediately apply a single-finger stroke to the activation assisted lever arm to activate the needle shielding mechanism (see Figure 5). NOTE: Activate away from self and others. Listen for click and visually confirm needle tip is fully covered. Figure 5 7

8 Disposal Pre-filled syringes are for single use only. This medicine may pose a risk to the aquatic environment. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 8